MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problem Thrombus (2101)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a venaseal kit for treatment of the patient¿s bilateral great saphenous vein (gsv).Ifu was followed.It is reported when treating the patient¿s right gsv, thrombus formation occurred when the guidewire was inserted.Treatment was discontinued.It is unknown if the guidewire caused the thrombus.Procedure rescheduled once superficial vein thrombosis (within gsv) subsides.No patient harm has been reported.Treatment is being performed but it is not yet confirmed if the thrombus has resolved.

Manufacturer Narrative

Additional information: patient attended a follow-up appointment but no medication or treatment was administered.Product analysis: the venaseal components were returned to medtronic investigation lab for evaluation.Components returned for analysis include: a dispenser gun, a vial, guide wire , a needle and catheter being attached to the syringe barrel.No images of the thrombus was received.The 0.035in guide wire was returned in its transportation hoop.Visual inspection of the guide wire revealed no abnormality or deformity.No damage was noted on its distal tip.The working length of the guide wire measured to 180cm.The product specification show the guide wire length is within specification.The returned 0.035in guide wire show no abnormality or deformity that would have caused the reported event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10419379
• MDR Text Key: 203287179
• Report Number: 9612164-2020-03008
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 57438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 48